QA Manager

Switzerland, SteinToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The primary purpose of the role is to ensure a Right First Time in Inspection Readiness for a Big CAPEX Project (encompassing a Fill Finish Facility, Laboratories, Warehousing, Shipment, and Offices)

The Incumbent will prepare for and drive all Quality Elements defined in the Operational Readiness Strategy, align within the global DPS Network, global Quality Management, MSAT, and Engineering specifically in
- Ensuring the Facility Design will meet the endpoints of a highly efficient, state of the Art, compliant Facility (meeting current and future regulatory expectations)
- Defining the framework for the Quality Management System (of a commercial DPS facility) and ensure an efficient documentation management system to obtain and maintain the right to operate
- Designing, facilitating and executing, the overall Contamination Control Strategy for the project; defining a life cycle management approach in line with progression of the project and global implementation
- Supporting and advising on the execution of Quality Standards

**Key Responsibilities**:

- Develop and Lead the implementation of the Quality Management Systems for the Big CAPEX Project, leveraging and improving existing DPS network standards and aligning with the regulatory landscape
- Ensure consistency of Design Decisions with URS and respective Risk Assessment, elevate risks in light of future operational readiness and define mitigation strategies
- Drive the design of a contamination control strategy in line with regulatory expectations and ensure a life cycle management in line with global standards / project progression
- Translate the project schedule in Quality Management Activities, monitor the critical path, and escalate risks with respect to to right first time execution, timelines, and budget
- Drive investigations, trouble shootings, host audits and inspection (from local and global regulators)

**Key requirements**:

- Master’s Degree or equivalent experience, Quality Management, Life Science, Pharmaceutical Sciences, or related science discipline
- Strong evidence of experience in a regulated pharmaceutical industry including engineering, manufacturing, quality assurance, quality control, R&D and/or drug regulatory affairs
- Experience of chemical and biological GMP API, aseptic Drug Product Manufacturing with demonstrated ability to interpret and implement related quality and regulatory requirements.
- Proven management experience in an EMA / FDA regulated environment, and have an excellent working knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.
- Experience in QA aspects of facility design to build a compliant but cost effective plant (area classification, CQV requirements etc.)
- Experience of planning and execution of large projects (resource planning, the timing of regulatory meetings with the inspection authorities, audit needs etc.)
- Knowledge of modern CQV approaches to minimize the time from construction completion to routine production while maintaining compliance
- Excellent German and English skills (spoken and written)

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

LI-SG1

**Reference: R56991**:

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